Registration Dossier
Registration Dossier
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EC number: 614-637-2 | CAS number: 68603-75-8
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The classification of the key parameter is based on results of the study " IFM 1981d" (Dunkin-Hartley guinea pigs, Magnusson Kligmann test + pretest) considered to be reliable with restrictions (Klimisch score 2). No further studies are available. Therefore the substance is deemed not to be a skin sensitizer.
After challenge application three males and five females exhibited a grade 1 (slight) erythema after 24h. This cutaneous reaction persisted in the same males and in only three females at the 48-hour examination time. No cutaneous reactions were observed in other animals.
Migrated from Short description of key information:
The potential of the substance to induce delayed contact hypersensitivity was investigated using the Maximization method of Magnusson and Kligman. The test item was found to be non-sensitising (Gobron, 1981d)
Respiratory sensitisation
Endpoint conclusion
- Additional information:
No information on the sensitising potential of the substance via the inhalation route is available. As Dinoram SL is not considered as a sensitizer via the dermal route the risk that the substance is a respiratory sensitizer is regarded as negligible.
Migrated from Short description of key information:
- No information on the sensitising potential of the substance via the inhalation route is available.
Justification for classification or non-classification
Skin sensitisation:
According to the results of the guinea-pig maximization test and the criteria laid down in EU regulation (EC) n°1272/2008 (CLP) and EU Directive 67/548/EEC, the substance is not classified for skin sensitisation.
Respiratory sensitisation:
No information on the sensitising potential of the substance via the inhalation route is available. As the substance is not considered as a sensitizer via the dermal route the risk that the substance is a respiratory sensitizer is regarded as negligible. Based on this reasoning the substance does not need to be classified for respiratory sensitization according tothe criteria laid down in EU regulation (EC) n°1272/2008 (CLP) and EU Directive 67/548/EEC.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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